Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children younger than 13 years of age with schizophrenia, in children younger than 10 years of age with bipolar disorder, or in children younger than 5 years of age with autistic disorder. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to be sensitive to the effects of risperidone, and have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving risperidone. This medicine should not be used for behavioral problems in older adults with dementia.

Pregnancy

Information about this risperidone-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Bepridil

Cisapride

Levomethadyl

Mesoridazine

Metoclopramide

Pimozide

Piperaquine

Terfenadine

Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Ajmaline

Amiodarone

Amisulpride

Amitriptyline

Anagrelide

Aprindine

Aripiprazole

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Bretylium

Bupropion

Buserelin

Chloral Hydrate

Chloroquine

Chlorpromazine

Citalopram

Clarithromycin

Crizotinib

Dabrafenib

Delamanid

Desipramine

Deslorelin

Dibenzepin

Disopyramide

Dofetilide

Dolasetron

Domperidone

Doxepin

Droperidol

Encainide

Enflurane

Erythromycin

Escitalopram

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gemifloxacin

Ginkgo Biloba

Gonadorelin

Goserelin

Halofantrine

Haloperidol

Histrelin

Hydromorphone

Hydroquinidine

Ibutilide

Imipramine

Ivabradine

Ketoconazole

Leuprolide

Linezolid

Lithium

Lorcainide

Mefloquine

Metronidazole

Milnacipran

Moxifloxacin

Nafarelin

Nortriptyline

Octreotide

Ondansetron

Pasireotide

Pazopanib

Pentamidine

Probucol

Procainamide

Prochlorperazine

Propafenone

Protriptyline

Quetiapine

Sematilide

Sertindole

Sertraline

Sevoflurane

Simvastatin

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Tedisamil

Telithromycin

Tetrabenazine

Tramadol

Trifluoperazine

Trimethoprim

Trimipramine

Triptorelin

Vandetanib

Vemurafenib

Vinflunine

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Carbamazepine

Cimetidine

Fosphenytoin

Itraconazole

Lamotrigine

Levorphanol

Methadone

Midodrine

Paroxetine

Phenobarbital

Phenytoin

Ranitidine

Ritonavir

Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Aspiration pneumonia, risk or history of or

Blood circulation problems or

Dehydration or

Dementia, such as decreasing mental ability or

Difficulty swallowing—May cause side effects to become worse.

Breast cancer, prolactin-dependent or

Diabetes or

Epilepsy or other seizure disorders or

Heart or blood vessel problems, including stroke and unusual heartbeats or

Hyperglycemia (high blood sugar) or

Hyperprolactinemia (high prolactin in the blood) or

Parkinson disease—May make these conditions worse.

Kidney disease or

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make this condition worse.